System and method for medical testing

ABSTRACT

A method of analyzing a medical condition includes creating a wireless communication link between a base unit and a test device at a first location, initiating a test protocol utilizing the test device at the first location, remotely controlling the test protocol with the base unit, generating test data using the test device according to the test protocol, and transmitting the test data to a second location at a different site than the first location. The test data is indicative of performance of a physiological function.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/186,621 filed Feb. 21, 2014, entitled SYSTEM AND METHOD FORCARDIOVASCULAR TESTING, which is a continuation of U.S. patentapplication Ser. No. 13/483,654 filed May 30, 2012 entitled SYSTEM ANDMETHOD FOR CARDIOVASCULAR TESTING, now U.S. Pat. No. 8,688,472, which iscontinuation of U.S. patent application Ser. No. 13/181,959 filed Jul.13, 2011 entitled SYSTEM AND METHOD FOR CARDIOVASCULAR TESTING, now U.S.Pat. No. 8,229,762, which is a continuation of U.S. patent applicationSer. No. 10/227,770 filed Aug. 26, 2002 entitled SYSTEM AND METHOD FORTESTING FOR CARDIOVASCULAR DISEASE, now U.S. Pat. No. 7,983,930, andclaims priority from U.S. Provisional Patent Application Ser. No.60/314,907 filed Aug. 24, 2001 entitled CARDIOVASCULAR DISEASEDIAGNOSTIC METHOD. Said applications are incorporated herein byreference.

TECHNICAL FIELD

The present invention relates to the field of medical diagnostics andmore particularly to devices and methods for measuring attributes ofhuman body systems.

BACKGROUND OF THE INVENTION

Cardiovascular disease is the number one killer in the United States.According to the American Heart Association, cardiovascular diseaseinflicts over 59 million Americans and contributes to approximatelysixty percent of all deaths recorded each year. This deadly diseaseattacks both men and women, equaling the next seven leading causes ofdeath combined for men and causing one out of every two deaths in women.Treatment options for cardiovascular disease are continuing to expand.However, patients are often diagnosed too late to be treated effectivelyor without invasive measures. Accordingly, early diagnosis and earlytreatment are vital to ensure successful outcomes.

To date, tools for obtaining such an early diagnosis have been difficultto access. Typically, devices for measuring blood flows through arteriesand veins (which are necessary for diagnosing cardiovascular disease)are large and expensive. Further, interpretation of the results of suchtesting require the doctor performing such tests to have special skills.As a result, such testing is usually performed only in vascularlaboratories in large hospitals. Here, the cost of having equipment andthe necessary doctor expertise can be justified through the volume ofpatients using such equipment. Yet a patient may not go to a hospitaluntil the cardiovascular disease has progressed to an advanced stage.Accordingly, it is desirable to perform such tests on a more routinebasis.

SUMMARY OF THE INVENTION

In one aspect, a method of analyzing a medical condition according tothe present invention includes creating a wireless communication linkbetween a base unit and a test device at a first location, initiating atest protocol utilizing the test device at the first location, remotelycontrolling the test protocol with the base unit, generating test datausing the test device according to the test protocol, and transmittingthe test data to a second location at a different site than the firstlocation. The test data is indicative of performance of a physiologicalfunction.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a block diagram of the inventive system.

FIG. 2 is a block diagram of a test unit of the presently inventivesystem.

FIG. 3 is a screen display of a computer used as part of the test unit.

FIGS. 4-9 are patient data entry screens of the computer.

FIGS. 10-12 are testing setup screens.

FIG. 13 is a test data display screen.

FIG. 14 is a physical exam data entry screen.

FIG. 15 is a block diagram of the intermediate computer.

FIG. 15A is a flow chart of a preferred record creation process forrecords to be transmitted to a diagnosis center.

FIG. 15B is a flow chart of a preferred record creation process forrecords to be transmitted to a payer center.

FIG. 16 is a block diagram of a diagnosis center.

FIG. 17 is a block diagram of a payer center.

DETAILED DESCRIPTION OF THE INVENTION

The present invention is a system and method for performing testing forcardiovascular disease. A test unit is used to measure parametersrelated to blood flow in a patient. The test unit stores the test datain association with a patient record containing patient data. The testunit is preferably a low cost unit that can be located at a generalpractitioner's office so that the testing can be performed as a routinepart of the general practitioner's care.

Once the testing is done, the patient record including the test data isthen transmitted to a diagnostic center for review and any necessarydiagnosis. The diagnosis center could be physically remote from thetesting unit, for example at a hospital. By setting up a number of testunits at varied locations with the test data being sent to diagnosiscenters, the frequency of tests can be increased while still havingdiagnosis performed by experts. The result is increased and accuratetesting for cardiovascular disease.

In a preferred embodiment, the patient record is routed to a diagnosisunit that performs predefined diagnosis tests on the test data. Thediagnosis tests then prepare a report for expert review andconfirmation.

In a further preferred embodiment, the patient record is routed to apayer center that can receive information regarding the performance of amedical test and process payment for the testing based upon thepatient's insurance coverage.

An intermediate computer can be used to route records from a test centerto a diagnosis center and/or a payer center. The intermediate computercan strip information from a patient record so that only necessaryinformation is sent to the diagnosis center and the payer center. Theintermediate computer may also store and execute diagnostic routines forensuring the proper operation of the medical testing equipment at thetest centers.

Referring now to FIG. 1, thereshown is a testing system 10 of thepresent invention. Test units 15A-C may be located at multiplelocations, such as at doctors' offices. The test units may includemedical testing devices such as an electronic sphygmomanometer coupledto a computer. The computer is setup to store patient records includingtest data produced by the medical testing devices. The test units areconnected to the public communications network 20 including thetelephone network, the internet and other dedicated electroniccommunication facilities. In a preferred embodiment, the test data issent to an intermediate server 25 for holding. Diagnosis centers 35 A-Ccan connect to the intermediate server to download the test data foranalysis.

Alternatively, the test unit may send the test data to the intermediateserver via e-mail and the intermediate server may then forward thee-mail to a selected diagnosis center. In still another alternativeembodiment, a direct connection via the public communications network 20could be established between the test unit and the diagnosis center. Insummary, there are many methods of communication between the test unitand the diagnosis unit.

In addition, the system can be used to automatically seek and obtainpayment for the testing from appropriate insurance providers (asavailable), the intermediate server may be connected via the publiccommunications network to payers (which may be insurance companies)30A-C.

Shown is FIG. 2 is a block diagram of a test unit. In a preferredembodiment, the test unit comprises a computer 100 and a medical testsystem such as an electronic sphygmomanometer. In operation, thecomputer can be used to track data associated with the patient, thedoctor and the test being performed. The computer 100 is also programmedto control the operation of the medical test system. The computer has acentral processing unit (CPU) 105, a data entry device such as akeyboard 110, a memory 115, a display 120 and an external communicationsdevice (such as a network card or a modem) 125. The medical test system150 is connected to the computer and provides data to the computer forstorage in memory 115. In particular, memory 115 may hold a database ofpatients along with associated personal and test data. Note however thatthe specific construction of the computer is not limited to thedisclosed structure. Many other structures of computer will still fallwithin the spirit of the present invention.

Referring now to FIG. 3, thereshown is a screen print of a computerdriven menu of a test unit 15. As can be seen, many choices areavailable to the operator of the test unit. On the selection of thepatient testing option, a screen such as the one shown in FIG. 4 may bedisplayed.

In FIG. 4, a user of the test unit would be given the option of adding apatient record to a database, editing a patient record already in thedatabase, testing a selected patient, searching for selectedinformation, deleting a patient record from the database, or exitingfrom the screen.

If the user selects the add a patient option, the test unit may thendisplay the screen shown in FIG. 5 so that the user can setup a patientrecord. At this screen, the user is offered the opportunity to enterdata about the patient, such as last name, first name, a patientidentification number, name of a referring doctor, name of an attendingdoctor, patent location, patient address including city and state, alist of any medications the patient is currently taking, patient height,patient weight, sex and age of the patient and the patient's socialsecurity number. Not shown but also included in patient data entry isthe patient's medical insurance information. Many other fields may beentered for tracking of desired information.

Further patient record information may be entered in connection withFIGS. 6-9. FIG. 6 is a screen print of another patient data entry screenat which data associated with previously diagnosed conditions of thepatient may be entered. In FIG. 7, the user is given the opportunity toenter comments into the patient's record. In FIG. 8, the user may entersymptoms experienced by the patient and risk factors associated with thepatient into the patient's record. FIG. 9 shows a screen at whichphysical signs and symptoms may be entered into the patient's record.

Once a patient record has been created, a specific test series can beentered for a patient as shown in FIG. 10. As examples, a number ofdifferent test protocols may be stored in the computer. In the presentexample, the possible test protocols are a Lower Extremity Arterial,Lower Extremity Venous, Upper Extremity Arterial, Upper Extremity Digit,Lower Extremity Digit, Cerebrovascular and Urology. A user would selecta desired test and test data would then be set up accordingly. Here, aLower Extremity Arterial test is selected.

In FIG. 11, the type of sensing or mode, may be selected. In the presentexample, PVR or Pulse Volume Recording is selected. Other methods caninclude Doppler, Segment Pressure, Post Examination Segment Pressure,Post Examination PVR, Post Procedure Segment Pressure and Post ProcedurePVR.

Once the test protocol and mode are selected, the body location beingtested may be selected. The data entry screen for such selection isshown in FIG. 12. The body part list being presented may depend from theseries of tests that has been selected. For the Lower Extremity Arterialtest, the location of the test could be at least the Right Upper Thigh,Right Leg above the Knee, Right Calf, Right Ankle, Right Foot, Toe onRight Foot, and the same locations on the left side.

Referring now to FIG. 13, thereshown is an exemplary display of a testresult screen. In particular, once a test has begun, results may beplotted on the grid area of the screen for displaying of measured testparameters. In FIG. 14, results from a physical examination of, forexample, pulse at a number of locations may be entered into thepatient's record to be associated with a set of test data.

Referring now to FIG. 15, thereshown is a preferred embodiment of theintermediate server 25. The computer has a central processing unit (CPU)205, a data entry device such as a keyboard 210, a memory 215, a display220 and an external communications device (such as a network card or amodem) 225.

The intermediate computer may perform a number of different functionsincluding storage of received patient records, transmission of all orpart of patient records to a diagnosis center, transmission of all orpart of patient records to payers, tracking of testing statistics (e.g.tests performed by site, diagnoses done per site, payments made bysite), performing diagnostic checks on test units and the like. Notehowever that the specific construction of the computer is not limited tothe disclosed structure. Many other structures of computer will stillfall within the spirit of the present invention.

One of the important functions performed by the intermediate computer ina preferred embodiment of the invention is to remotely assume control ofthe test unit at the general practitioner's site by controlling thecomputer in the test unit. Such remote control allows the technicalsupport personnel at the intermediate computer to remotely provideassistance to an operator of the test unit at the general practitioner'ssite. Typically, an operator using the test unit has training as anend-user of the unit but may from time to time need technical help fromthe experts at the test unit provider. For example, when an operatorencounters difficulties using the test unit, technical support personnelcan take over the control of the test unit and be able to determine thecause of the difficulties, resolve the difficulties and return thecontrol back to the operator. Such a mode of operation can drasticallyreduce the number of resources in the field needed by the test unitprovider and thus result in a more economical operation of the entiresystem.

The remote control can be achieved by any suitable scheme well known inthe art. For example, a remote display system known as the “VirtualPrivate Network”, or “VPN” can be used to allow a person at theintermediate computer to take over the test unit after permission forsuch control is granted by an authorized person at the test unit.

Each patient record will include test data from a test. In one preferredembodiment, the intermediate computer will transmit the test data alongwith patient identifying information to a diagnosis center. While all ofa patient record may be shipped to a diagnosis center with each testbeing diagnosed, in a preferred embodiment, only a limited set ofpatient identifying information, along with all relevant medicalinformation will be sent. The information from a patient record that isforwarded on to a diagnosis center could be preselected for each type oftest. This structure allows for efficient use of communications assetsand assists in the maintenance of privacy of patient data. This processis shown in FIG. 15A. While the steps in FIG. 15A are shown as in asequence, this provided by way of example, not limitation. As onealternative, the necessary patient identification information may beselected before the relevant medical information or they may be selectedin parallel. The spirit of the invention requires selection of thisinformation, not a particular order for the selection.

The patient record will also contain information about performance of atest that was the reason the patient record was sent to the intermediatecomputer. In a preferred embodiment, on receipt of a patient record, theintermediate server 25 analyzes the patient record, identifies teststhat have been performed, the doctor performing the test, and theinsurance company associated with the patient. The intermediatecomputer, in a preferred embodiment, stores a database of medicalprocedure codes and associates a medical procedure code with the testperformed. Thereafter, the intermediate server may automatically notifythe insurance company of the receipt of a record requiring the company'sattention. Alternatively, the intermediate server could storeinformation about the new record to be shipped to the insurance companyupon a request to the intermediate server to do so. This process isshown in the flow chart of FIG. 15B. As in FIG. 15A, while the elementsof FIG. 15B are shown in a sequence, this is provided by way of example,not limitation. As one alternative, the necessary patient identificationinformation may be selected before the identification of the relevantmedical procedure code or they may be selected in parallel. The spiritof the invention requires selection of this information, not aparticular order for the selection.

A still further function of the intermediate computer 25 may be toperform diagnostics on test units 15 and in particular on medical testdevices 150. The intermediate computer 25 may store test routines thatcan be performed by a trained expert through connection to the test unit15. In particular, a direct dial up connection, a network connectionthrough software such as PC Anywhere software, or a web interfaceconnection could be used to have the test unit perform certain functionsand report results back to the intermediate computer.

Another function of the intermediate computer 25 can be to providetraining remotely to the end-users of the medical test devices 150.Training can be provided in a number of effective ways. One approach isinstalling an automated training program on the intermediate computer15, which the end-users can remotely access to download lessons. Anotherapproach is to have live training, with the trainer illustrating theoperations by controlling the trainee's testing unit as discussed above.

Referring now to FIG. 16, there shown is a preferred embodiment of adiagnosis center 35 which may include a computer 300 with a connectionto the public communications network 20. Computer 300 may include acentral processing unit (CPU) 305, a data entry device such as akeyboard 310, a memory 315, a display 320 and an external communicationsdevice (such as a network card or a modem) 325. The diagnosis center mayeither receive records sent from the intermediate computer, may connectto the intermediate computer through the public communications network20 or may receive records through a direct connection to a test center15.

Upon receipt of a record, the intermediate computer at the diagnosiscenter forwards the record to a diagnostician for interpretation of therecord. The forwarding process can be carried out in a variety ofwell-known ways. For example, the intermediate computer may simplynotify a diagnostician that a record has arrived at the diagnosiscenter. The diagnostician can then indicate whether he or she will takethe case, and if he or she does, download a copy of the record.

A diagnostician can provide diagnosis based on the record in anysuitable manner. For example, in an automated and paperless process, adiagnostician can fill out an electronic record analysis form thataccompanies the record. based on his or her review of the record.

After a diagnostician has completed his or her analysis of the record,he or she can then transmit the analysis back to the generalpractitioner who provided the record. Under typical medical insurancesystems, such analyses are legal documents that must be validly executedby the physicians performing the analyses. Thus, according to one aspectof the invention, the diagnosticians are provided with computers thatare equipped with signature recorders that are capable of biometricrecognition. Thus, an electronic diagnosis form electronically signed bya diagnostician is compliant with the Health Insurance Portability andAccountability Act (HIPAA). Such signature recorders are well known andhave numerous applications, such as credit card authentication.

It should be pointed out that the invention enables the efficientmanagement of a highly flexible diagnostic service system. The testdevices need not to be identical; in fact, they can be devices fordiagnosing entirely different medical conditions. Correspondingly,diagnosticians of a diverse set of specialties can be enlisted tointerpret the test data. The intermediate computer thus can also serveas a manager that directs work flow by routing requests forinterpretation to the appropriate diagnosticians depending on theoriginating test device. The information on the types of tests eachdevice is capable of making and the appropriate diagnosticians can bestored in a database associated with the intermediate computer as abasis for determining diagnostic work flow.

Referring now to FIG. 17, there shown is a preferred embodiment of abilling center 300 which may include a computer 400 with a connection tothe public communications network 20. Computer 400 may include a centralprocessing unit (CPU) 405, a data entry device such as a keyboard 410, amemory 415, a display 420 and an external communications device (such asa network card or a modem) 425. The diagnosis center may either receiverecords sent from the intermediate computer, may connect to theintermediate computer through the public communications network 20 ormay receive records through a direct connection to a test center 15.

The billing center computer may store itself or be connected to othercomputing resources from which information about the patient may berecalled. For example, the billing center may store information aboutthe patient's prior medical history, recent tests, level of coverage,deductible, year to date payments, ordinary and customary paymentlevels, lifetime payment limits and other factors affecting coverage.

In a preferred embodiment, the billing center computer manages billssent to payers by optimizing either electronic or paper filings with theappropriate payer. The billing center computer receives billinginformation from the parties (e.g., testers and interpreters) seekingpayments from the payers (e.g., insurance carriers) for the medicalservices rendered. Such billing information typically includes payerinformation, patient identification, a description of services renderedand amount billed for the services. The description of services renderedcan be in the form of a set of predefined codes. The billing centercomputer then transmits the billing information to the appropriatepayers, or sends a payment request notice to the payers and provides thepayers access to the details of billings at the billing center computer.

Each payer may have its own system for determining the amount ofpayment. Upon receipt of a record requesting payment, payers may accessinformation from the billing center to determine the payment amount tobe paid. The payers can then send reimbursements directly to the testersand interpreters.

In a further embodiment, the billing center computer can also managebilling for the diagnostic system services provided to the test andinterpretation participants. This is performed by tracking the number oftests performed on a periodic basis and invoicing based on a serviceagreement in place with each interpreter and tester.

In another embodiment, wireless technology is employed to furtherenhance the system performance. For example, commercial wirelessservices such as Blue Tooth™ can be used to facilitate automatic testdata transfer. In particular, portable field test devices can includewireless receivers and transmitters. A base unit including a computer,radio frequency beacon and receivers can be installed at a physician'sclinic. When a test device is brought back from the field (such aspatient's homes) to the clinic, the receiver on the test device detectsthe beacon and subsequently causes the transmitter to transmit a signalindicating the presence of the test device. Upon the receiver of thebase unit detecting the signal, the base unit computer begins a wirelessdownload of the test data and transfer the downloaded data to theintermediate computer. Thus, the transmission of test data fordiagnostic interpretation is automated.

The invention optimizes the process of providing medical diagnosticservices. It utilizes computers and computer networks to economicallyplace diagnostic devices where they are the most effectively used whileplacing the data produced by these devices within easy reach of theexpert interpreters of the data. The efficiency and quality of serviceis enhanced by such features as remote control and troubleshooting ofthe test devices, remote training and centralized billing process. As aresult, satisfactory financial arrangements can be made to allowprimary-care physicians to more timely use diagnostic devices previouslypredominately available only in large diagnostic centers. For example, adiagnostic system service provider can lease to a physician a device andcharge the physician on a per-test basis, rather than charging a largemonthly sum that will require a certain minimum number of tests to reachthe break-even point for the physician.

The particular embodiments disclosed above are illustrative only, as theinvention may be modified and practiced in different but equivalentmanners apparent to those skilled in the art having the benefit of theteachings herein. Furthermore, no limitations are intended to thedetails of construction or design herein shown, other than as describedin the claims below. It is therefore evident that the particularembodiments disclosed above may be altered or modified and all suchvariations are considered within the scope and spirit of the invention.Accordingly, the protection sought herein is as set forth in the claimsbelow.

What is claimed is:
 1. A method of analyzing a medical condition, themethod comprising: creating a wireless communication link between a baseunit and a test device at a first location; initiating a test protocolutilizing the test device at the first location; remotely controllingthe test protocol with the base unit; generating test data using thetest device according to the test protocol, wherein the test data isindicative of performance of a physiological function; and transmittingthe test data to a second location at a different site than the firstlocation.
 2. The method of claim 1, wherein the step of creating thewireless communication link between the base unit and the test device ata first location comprises: transmitting a beacon from the base unit;and detecting the beacon with the test device.
 3. The method of claim 2and further comprising: transmitting a signal from the test device tothe base unit after detecting the beacon.
 4. The method of claim 3 andfurther comprising: automatically downloading the test data to a serverwhen the base unit receives the signal transmitted from the test device.5. The method of claim 1 and further comprising: remotely controllingthe test device for training purposes.
 6. A method comprising:generating test data using a test device according to a test protocol,wherein the test data is indicative of performance of a physiologicalfunction; establishing a communication link between the test device anda server, wherein the server is located remotely from the test device;determining a cause of difficulty associated with the test device; andremotely controlling the test device via the server for trainingpurposes.
 7. The method of claim 6 and further comprising: performingdiagnostics on the test device via the server to ascertain whether ornot a technical problem is present in the test device.
 8. The method ofclaim 7 and further comprising: reporting results of the diagnosticsperformed on the test device to the server.
 9. The method of claim 6 andfurther comprising: transmitting the test data to a second location at adifferent site than the first location.
 10. The method of claim 6 andfurther comprising: creating a wireless communication link between abase unit and the test device.
 11. The method of claim 10, wherein thestep of creating the wireless communication link between the base unitand the test device comprises: transmitting a beacon from the base unit;and detecting the beacon with the test device.
 12. The method of claim6, wherein the test device is controlled for a live training session foran operator present at the test device.
 13. The method of claim 6,wherein an automated training protocol from the server is run on thetest device.
 14. A system for testing and interpretation of a medicalcondition, the system comprising: a test device and configured toperform a medical testing protocol for generating test data, the testdevice configured to store a record containing test data and patientinformation, the test device further configured to transmit the record;a recipient computer configured to receive the record from the testdevice, the recipient computer configured to display the test data, thetest device and the recipient computer located at different sites,wherein the recipient computer includes an input device configured toenter input indicative of a medical interpretation of the test data; aserver configured to communicate with the test device and the recipientcomputer and to store the record and the input indicative of a medicalinterpretation of the test data, the server located remote from both thetest device and the recipient computer at a different site; and a baseunit configured to wirelessly communicate with the test device tofacilitate data transfer between the test device and the server.
 15. Thesystem of claim 14, wherein the base unit is configured to detect thepresence of the test device and to transmit a signal to the server as afunction of detection of the presence of the test device.
 16. The systemof claim 14, wherein the base unit is configured to automaticallytransmit the test data to the server when presence of the test device isdetected.
 17. The system of claim 14, wherein the server is configuredto remotely run at least one of a training protocol and a devicediagnostic protocol on the test device.